|Publication number||US9414918 B2|
|Application number||US 14/019,332|
|Publication date||16 Aug 2016|
|Filing date||5 Sep 2013|
|Priority date||6 Sep 2012|
|Also published as||CA2882381A1, CN104768500A, CN104768500B, EP2892469A1, EP2892469A4, US9510946, US20140067048, US20140067052, US20140067054, US20160317290, WO2014039392A1|
|Publication number||019332, 14019332, US 9414918 B2, US 9414918B2, US-B2-9414918, US9414918 B2, US9414918B2|
|Inventors||Mark Chau, Travis Oba, Sergio Delgado, Robert C. Taft|
|Original Assignee||Edwards Lifesciences Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (356), Non-Patent Citations (28), Referenced by (3), Classifications (14), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. Provisional Patent Application No. 61/697,706, filed Sep. 6, 2012, and 61/763,848, filed Feb. 12, 2013, which are each hereby incorporated herein by reference in their entirety.
This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices.
The native heart valves (i.e., the aortic, pulmonary, tricuspid and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital malformations, inflammatory processes, infectious conditions or disease. Such damage to the valves can result in serious cardiovascular compromise or death. For many years the definitive treatment for such disorders was the surgical repair or replacement of the valve during open heart surgery. However, such surgeries are highly invasive and are prone to many complications. Therefore, elderly and frail patients with defective heart valves often went untreated. More recently, transvascular techniques have been developed for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery. Such transvascular techniques have increased in popularity due to their high success rates.
A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets extending downward from the annulus into the left ventricle. The mitral valve annulus can form a “D” shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally “C” shaped boundary between the abutting free edges of the leaflets when they are closed together.
When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates, the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract, the increased blood pressure in the left ventricle urges the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.
Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systole phase of heart contraction. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, dysfunctional papillary muscles and/or stretching of the mitral valve annulus resulting from dilation of the left ventricle. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation.
Some prior techniques for treating mitral regurgitation include stitching portions of the native mitral valve leaflets directly to one another. Other prior techniques include the use of a spacer implanted between the native mitral valve leaflets. Despite these prior techniques, there is a continuing need for improved devices and methods for treating mitral valve regurgitation.
This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices.
In some embodiments, a prosthetic device for treating heart valve regurgitation comprises a radially compressible and radially expandable body having a first end, a second end, and an outer surface extending from the first end to the second end and an anchor having a connection portion and a leaflet capture portion, wherein the connection portion is coupled to the body such that the leaflet capture portion is biased against the outer surface of the body when the body is in a radially expanded state, the prosthetic device is configured to capture a leaflet of a native heart valve between the leaflet capture portion of the anchor and the outer surface of the body, and the body is configured to prevent blood from flowing through the body in a direction extending from the first end to the second end and in a direction extending from the second end to the first end.
In some embodiments, the outer surface of the body comprises a first side against which the anchor is biased and a second side opposite the first side, and the connection portion of the anchor is coupled to the body on the second side of the body. In some embodiments, the anchor comprises an elongated member that is coupled to the second side of the body at a connection location and the elongated member comprises a ventricular portion that extends from the connection location across the first end of the body. In some embodiments, the ventricular portion comprises first and second ventricular portions and the first ventricular portion is substantially parallel to the second ventricular portion.
In some embodiments, the body is radially compressible to a compressed state in which a leaflet-receiving gap exists between the body and the leaflet capture portion of the anchor, and the body is resiliently radially self-expandable to the radially expanded state. In some embodiments, the anchor comprises a first clip portion and a second clip portion, and the device is configured to capture the leaflet between the first and second clip portions. In some embodiments, the body is formed from Nitinol and is radially self-expandable to the expanded state. In some embodiments, the body comprises a metallic frame and a blood-impermeable fabric mounted on the frame. In some embodiments, the body is configured to allow blood to flow around the body between the body and a non-captured leaflet during diastole, and configured to allow the non-captured leaflet to close around the body to prevent mitral regurgitation during systole.
In some embodiments, the anchor is coupled to the first end of the body and the device further comprises an atrial stabilizing member extending from the second end of the body. In some embodiments, the body is configured to move within the native heart valve along with motion of the captured leaflet. In some embodiments, an atrial end portion of the body comprises a tapered shoulder that reduces in diameter moving toward the atrial end portion of the body. In some embodiments, the body comprises a crescent cross-sectional shape. In some embodiments, the anchor comprises first and second anchors and the device is configured to be secured to both native mitral valve leaflets.
In some embodiments, a prosthetic device for treating heart valve regurgitation comprises a main body portion having a connection portion and a free end portion, wherein the connection portion is configured to be coupled to a first one of the two native mitral valve leaflets such that the device is implanted within a native mitral valve orifice, and when the device is implanted within the native mitral valve orifice, the free end portion moves laterally toward a second one of the two native mitral valve leaflets during systole, thereby helping to seal the orifice and reduce mitral regurgitation during systole, and the free end portion moves laterally away from the second native mitral valve leaflet during diastole to allow blood to flow from the left atrium to the left ventricle during diastole.
In some embodiments, the connection portion of the main body is thicker than the free end portion. In some embodiments, the main body portion further comprises an atrial portion that contacts the native mitral valve annulus within the left atrium adjacent to the first native mitral valve leaflet. In some embodiments, the device further comprises a ventricular anchor that clips around a lower end of the first native mitral valve leaflet, thereby securing the device to the first native mitral valve leaflet. In some embodiments, the anchor comprises a paddle shape with a broad upper end portion and a relatively narrow neck portion, wherein the neck portion couples the upper end portion to the main body.
In some embodiments, a prosthetic device comprises a sheet of flexible, blood-impermeable material configured to be implanted within a native mitral valve orifice and coupled to a first one of the two native mitral leaflets or to the native mitral annulus adjacent the first native mitral leaflet, wherein when implanted the sheet is configured to inflate with blood during systole such that a free portion of the sheet not coupled to the first native mitral leaflet or the mitral annulus adjacent the first native mitral leaflet moves laterally toward and seals against the second of the two native mitral leaflets to reduce mitral regurgitation, and when implanted the sheet is configured to deflate during diastole such that the portion of the sheet not coupled to the first native mitral leaflet or the native mitral annulus adjacent the first native mitral leaflet moves laterally away from the second native mitral leaflet to allow blood to flow from the left atrium to the left ventricle.
In some embodiments, the sheet is supported by a rigid frame that is secured to the first native mitral leaflet. In some embodiments, the frame comprises a ventricular anchor that clips around a lower end of the first native mitral leaflet. In some embodiments, the frame comprises an atrial portion that contacts the native mitral annulus within the left atrium adjacent to the first native mitral leaflet. In some embodiments, an upper end of the sheet is secured directly to the native mitral annulus adjacent the first native mitral leaflet or to the first native mitral leaflet adjacent the native mitral annulus. In some embodiments, the upper end of the sheet is secured to native tissue via rigid anchors that puncture the native tissue.
In some embodiments, the sheet comprises an annular cross-sectional profile perpendicular to an axis extending through the mitral orifice from the left atrium to the left ventricle. In some embodiments, the sheet comprises a closed atrial end and an open ventricular end. In some embodiments, the open lower end is biased toward an open position and is configured to collapse to a closed position during diastole. In some embodiments, the sheet is supported by a rigid frame that is secured to the first native mitral leaflet, and the frame comprises a plurality of longitudinal splines extending from the upper end of the sheet to the lower end of the sheet. In some embodiments, the splines are biased to cause the lower end of the sheet to open away from the first native leaflet.
In some embodiments, a lower end of the sheet is tethered to a location in the left ventricle below the native mitral leaflets. In some embodiments, the lower end of the sheet is tethered to the papillary muscle heads in the left ventricle. In some embodiments, the lower end of the sheet is tethered to a lower end of the rigid frame. In some embodiments, opposing lateral ends of the lower end of the sheet are tethered to the lower end of the frame such that an intermediate portion of the lower end of the sheet can billow out away from the frame and toward the second leaflet during systole. In some embodiments, the sheet has a generally trapezoidal shape, with a broader portion adjacent to the mitral annulus and a narrower portion positioned between the native mitral leaflets.
In some embodiments, a prosthetic device for treating heart valve regurgitation comprises a radially compressible and radially expandable body having a first end, a second end, and an outer surface extending from the first end to the second end, a first anchor coupled to the body and configured to capture the anterior native mitral valve leaflet between the first anchor and the body to secure the device to the anterior leaflet, and a second anchor coupled to the body and configured to capture the posterior native mitral valve leaflet between the second anchor and the body to secure the device to the posterior leaflet, wherein when the first and second anchors capture the anterior and posterior leaflets, the body is situated within a mitral valve orifice between the anterior and posterior leaflets, thereby decreasing a size of the orifice.
In some embodiments, the body is radially compressible to a collapsed delivery configuration suitable for delivering the device to the native mitral valve, and radially expandable from the collapsed delivery configuration to an expanded, operational configuration suitable for operation in the native mitral valve. In some embodiments, the body is formed from Nitinol and is radially self-expandable from the collapsed configuration to the expanded configuration. In some embodiments, the device further comprises a sheet of blood impermeable fabric covering the body. In some embodiments, the body has an elliptical cross-sectional shape. In some embodiments, the body has a crescent cross-sectional shape. In some embodiments, the body comprises a prosthetic valve. In some embodiments, the body is configured to prevent blood from flowing through the body in a direction extending from the first end to the second end and in a direction from the second end to the first end.
In some embodiments, a method of implanting a prosthetic sealing device at a native mitral valve of a heart comprises advancing a delivery catheter to a native mitral valve region of a heart from a left atrium of the heart, the delivery catheter housing the prosthetic sealing device in a radially compressed configuration, advancing the prosthetic sealing device distally relative to the delivery catheter such that an anchor of the prosthetic sealing device moves out of the catheter and forms a leaflet-receiving gap between an end portion of the anchor and the delivery catheter, positioning either a posterior or an anterior mitral valve leaflet in the gap, and advancing a radially compressed body of the prosthetic sealing device out of the delivery catheter such that the body self-expands radially toward the end portion of the anchor, reducing the gap, and capturing the leaflet between the body and the end portion of the anchor, wherein the body is configured to prevent the flow of blood through the body during systole and during diastole.
In some embodiments, a non-captured one of the anterior and posterior leaflets is not secured to the prosthetic sealing device when the prosthetic sealing device is implanted at the native mitral valve. In some embodiments, advancing a delivery catheter through the native mitral valve from a left atrium comprises advancing the delivery catheter through an incision in a portion of a septum between the left atrium and a right atrium. In some embodiments, when the delivery catheter is advanced to the native mitral valve region of the heart, the anchor is held in a substantially straightened position within the delivery catheter extending distally from body of the prosthetic sealing device.
In some embodiments, a method of implanting a prosthetic sealing device at a native mitral valve comprises advancing a delivery device to a native mitral valve region via a left ventricle, the delivery catheter housing the prosthetic sealing device in a compressed configuration, allowing an anchor of the prosthetic sealing device to move radially out of the delivery device while a body of the delivery device is in a compressed configuration, such that a leaflet-receiving gap forms between an end portion of the anchor and the delivery device, positioning either a posterior or an anterior mitral valve leaflet in the gap, and allowing the body of the prosthetic sealing device to radially self-expand such that the leaflet is captured between the body and the anchor, wherein the body is configured to prevent the flow of blood through the body during systole and during diastole.
In some embodiments, a non-captured one of the anterior and posterior mitral valve leaflets is not secured to the prosthetic sealing device when the prosthetic sealing device is implanted at the native mitral valve. In some embodiments, advancing a delivery device to a native mitral valve region via a left ventricle comprises inserting the delivery device into the left ventricle through an incision in an apex of the left ventricle.
In some embodiments, a method of implanting a prosthetic sealing device at a native mitral valve of a heart comprises advancing a delivery system to a native mitral valve region of a heart from a left ventricle of the heart, the delivery system housing the prosthetic sealing device in a radially compressed configuration, proximally retracting an outer sheath of the delivery system such that anchors of the prosthetic sealing device are not confined within the delivery system, advancing the delivery system toward the left atrium of the heart such that native mitral valve leaflets are positioned between the anchors of the prosthetic sealing device and the delivery system, proximally retracting an inner sheath of the delivery system such that a body of the prosthetic sealing device is not confined within the delivery system, wherein the body is configured to prevent the flow of blood through the body during systole and during diastole, and removing the delivery system from the native mitral valve region of the heart.
In some embodiments, advancing the delivery system to the native mitral valve region from the left ventricle comprises inserting the delivery device into the left ventricle through an incision in an apex of the left ventricle. In some embodiments, when the delivery system is advanced to the native mitral valve region of the heart, the anchor is held in a substantially straightened position within the delivery catheter extending distally along a side of the body of the prosthetic sealing device.
In some embodiments, a method of implanting a prosthetic sealing device at a native mitral valve of a heart comprises advancing a delivery system to a native mitral valve region of a heart from a left atrium of the heart, the delivery system housing the prosthetic sealing device in a radially compressed configuration, proximally retracting an outer sheath of the delivery system such that anchors of the prosthetic sealing device are not confined within the delivery system, retracting the delivery system toward the left atrium of the heart such that native mitral valve leaflets are positioned between the anchors of the prosthetic sealing device and the delivery system, proximally retracting an inner sheath of the delivery system such that a body of the prosthetic sealing device is not confined within the delivery system, wherein the body is configured to prevent the flow of blood through the body during systole and during diastole, and removing the delivery system from the native mitral valve region of the heart.
In some embodiments, advancing the delivery system to the native mitral valve region from the left atrium comprises advancing the delivery system through an incision in a portion of a septum between the left atrium and a right atrium. In some embodiments, when the delivery system is advanced to the native mitral valve region of the heart, the anchor is held in a substantially straightened position within the delivery catheter extending proximally from body of the prosthetic sealing device.
Described herein are embodiments of prosthetic devices that are primarily intended to be implanted at one of the mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as apparatuses and methods for implanting the same. The prosthetic devices can be used to help restore and/or replace the functionality of a defective native mitral valve. The disclosed embodiments should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another.
In some embodiments, a prosthetic device comprises a body and an anchor. The body is configured to be positioned within the native mitral valve orifice to help create a more effective seal between the native leaflets to prevent or minimize mitral regurgitation. The body can comprise a structure that is impervious to blood and that allows the native leaflets to close around the sides of the body during ventricular systole to block blood from flowing from the left ventricle back into the left atrium. The body is sometimes referred to herein as a spacer because the body can fill a space between improperly functioning native mitral leaflets that do not naturally close completely. In some embodiments, the body can comprise a prosthetic valve structure positioned within an annular body.
The body can have various shapes. In some embodiments, the body can have an elongated cylindrical shape having a round cross-sectional shape. In other embodiments, the body can have an ovular cross-sectional shape, a crescent cross-sectional shape, or various other non-cylindrical shapes. The body can have an atrial or upper end positioned in or adjacent to the left atrium, a ventricular or lower end positioned in or adjacent to the left ventricle, and an annular side surface that extends between the native mitral leaflets.
The anchor can be configured to secure the device to one or both of the native mitral leaflets such that the body is positioned between the two native leaflets. The anchor can attach to the body at a location adjacent the ventricular end of the body. The anchor can be configured to be positioned behind a native leaflet when implanted such that the leaflet is captured between the anchor and the body.
The prosthetic device can be configured to be implanted via a delivery sheath. The body and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured to allow the anchor to self-expand radially away from the still-compressed body initially in order to create a gap between the body and the anchor. The leaflet can then be positioned in the gap. The body can then be allowed to self-expand radially, closing the gap between the body and the anchor and capturing the leaflet between the body and the anchor. The implantation methods for various embodiments can be different, and are more fully discussed below with respect to each embodiment. Additional information regarding these and other delivery methods can be found in U.S. Patent Application Publication No. 2011/0137397 and U.S. Provisional Patent Application No. 61/760,577, which are incorporated by reference herein in their entirety.
Some embodiments disclosed herein are generally configured to be secured to only one of the native mitral leaflets. However, other embodiments comprise more than one anchor and can be configured to be secured to both mitral leaflets. Unless otherwise stated, any of the embodiments disclosed herein that comprise a single anchor can optionally be secured to the anterior mitral leaflet or secured to the posterior mitral leaflet, regardless of whether the particular embodiments are shown as being secured to a particular one of the leaflets.
Furthermore, some embodiments can optionally also include one or more atrial anchors, such as to provide additional stabilization. Unless otherwise stated, any of the embodiments disclosed herein can optionally include an atrial anchor or not include an atrial anchor, regardless of whether the particular embodiments are shown with an atrial anchor or not.
Some of the disclosed prosthetic devices are prevented from atrial embolization by having the anchor hooked around a leaflet, utilizing the tension from native chordae tendinae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive forces exerted on the leaflet that is captured between the body and the anchor to resist embolization into the left ventricle.
The device 20 is shown in an expanded configuration in
The body 22 can comprise an annular metal frame 32 covered with a blood-impervious fabric 28, as shown in
The frame 32 can be formed from a self-expandable material, such as Nitinol. When formed from a self-expandable material, the frame 32 can be radially compressed to a delivery configuration and can be retained in the delivery configuration by placing the device in the sheath of a delivery apparatus. When deployed from the sheath, the frame 32 can self-expand to its functional size. In other embodiments, the frame can be formed from a plastically expandable material, such as stainless steel or a cobalt chromium alloy. When formed from a plastically expandable material, the prosthetic device can be crimped onto a delivery apparatus and radially expanded to its functional size by an inflatable balloon or an equivalent expansion mechanism. It should be noted that any of the embodiments disclosed herein can comprise a self-expandable main body or a plastically expandable main body.
Note that, while
The device 70 can be can be deployed from a delivery catheter according to the method illustrated with respect to device 50 in
Because the anchor 74 extends around the ventricular end 78 of the body, the first portions 84, 86 can be provided with a larger radius of curvature compared to if the anchor 74 was connected to the body 72 on the same side as the end portion 92. This large radius of curvature of the first portions 84, 86 can provide greater control over the clamping forces between the end portion 92 and the body 72, and provide a more robust and durable anchor configuration, reducing stress concentrations in the anchor 74 and connection points 80, 82. Because the body is acting as a spacer, causing the blood to flow around it, the anchor 74 can pass around the ventricular end 78 of the body without obstructing the flow of blood any more than necessary. Having the anchor members 84, 86 positioned below the ventricular end of the body may not be as desirable in embodiments where the body comprises an annular frame with a prosthetic valve within the annular frame, since the members 84, 86 could restrict the flow of blood through the body to some degree.
In the case of the device 70, when the device is clipped onto a mitral leaflet between the end portion 92 and the second side of the body 72, a majority of the blood flow passes around the other three sides of the body (i.e., the left, right, and bottom side in
The exemplary prosthetic devices disclosed herein can be delivered to the mitral region via plural different approaches.
During systole, as illustrated in
During diastole (not shown), P1 exceeds P2 causing the parachute 206 to deflate and collapse toward the structural portion 202. At the same time, the two native leaflets 6, 8 are pushed apart. This allows blood to flow from the left atrium to the left ventricle with minimal obstruction by the collapsed parachute 206.
In some embodiments, the device 200 can comprise additional structural elements. For example, some embodiments can comprise longitudinal splines that extend from the upper end 210 to the lower end 208 to provide longitudinal rigidity to the parachute without impeding expansion/contraction in the radial direction, much like a common umbrella. In some embodiments, the device 200 can comprise a structural member at the lower opening 208 to prevent the lower opening from fully closing during diastole, such that blood can more easily enter the lower opening at the beginning of systole. In some embodiments, the device 200 can comprise a biased portion that urges the lower opening 208 toward an opened position. The biased portion can comprise a spring mechanism, resiliently flexible members, or other mechanisms. In some embodiments, the device 200 can further comprise an atrial portion that extends from or adjacent to the upper end 210 and contacts the atrial walls and/or the atrial side of the leaflet to which the device is attached. The atrial body can help secure the device within the mitral orifice and can prevent movement toward the left ventricle. The atrial body can comprise a separate component or an extension of the structural member 202. The atrial body can be configured like the atrial bodies 26A, 26B or 26C described above, or can have other configurations.
By anchoring a prosthetic mitral device to one of the mitral leaflets, as disclosed herein, instead of anchoring the device to the walls of the left ventricle, to the walls of the left atrium, to the native valve annulus, and/or the annulus connection portions of the native leaflets, the device anchorage is made independent of the motions of the ventricular walls and atrial walls, which move significantly during contractions of the heart. This can provide a more stable anchorage for a prosthetic mitral device, and eliminate the risk of hook-type or cork screw-type anchors tearing or otherwise causing trauma to the walls of the left ventricle or left atrium. Furthermore, the device body can be held in a more consistent position with respect to the mitral leaflets as the leaflets articulate, eliminating undesirable motion imparted on the device from the contraction motions of the left ventricle walls and left atrium walls. Anchoring to a mitral leaflet can also allow for a shorter body length compared to devices having other anchorage means.
During systole, as shown in
During diastole, as shown in
During systole, as shown in
During diastole, as shown in
In use, the free end portions 508, 510 extend the effective length of the respective leaflets, and can facilitate initiation of leaflet coaptation during ventricular systole. During systole, the leaflets are urged toward one another due to the pressures extant in the left ventricle and left atrium. Due to the extended effective length of the leaflets, the end portions 514, 516 are more likely to coapt than were the ends of the native leaflets without the extensions. Once coaptation is initiated, and thus blood flow from the left ventricle to the left atrium at least partially impeded, the pressure in the left ventricle can increase, further increasing the pressure differential between the left ventricle and the left atrium and urging the leaflets 6, 8, further toward one another.
As a result, the portions of the leaflets 6, 8, and their respective extensions 502, 500 which coapt, increases (both in the direction from the end portions 514, 516 toward the left atrium 2, and from the locations of the devices 500, 502, toward the commissure points of the mitral valve), leading to a cycle of increasingly impeded blood flow, increased pressure differential, and increased coaptation of the leaflets. Thus, by facilitating initiation of coaptation, the free end portions 508, 510 can help to reduce regurgitation of blood from the left ventricle to the left atrium during ventricular systole. Further, the upper portions 504, 506 can further help to prevent regurgitation in the manner described above with respect to prosthetic device 10. In cases where the native leaflets 6, 8, do not experience sufficient coaptation to prevent regurgitation, the relatively thick upper portions 504, 506, can help to increase their coaptation and thereby reduce regurgitation.
Spacers Having Plural Anchors
In some embodiments, prosthetic devices can include a body and a plurality of anchors such that the body can be clipped to more than one leaflet. Such embodiments can be used to effectively couple two or more leaflets to one another. Thus, such a device can be used to bring native leaflets closer to one another and restrict their mobility in order help increase the chance of or extent of coaptation between the leaflets.
In alternative embodiments, the body of a dual anchor spacer can have various alternative shapes. For example, cross-sectional profile of the body can be circular, elliptical, or as shown in
A suitable delivery sequence for delivering a prosthetic spacer such as spacer 750 to the mitral valve region of a patient's heart can comprise compressing a spacer to a compressed, delivery configuration, delivering the spacer to the coaptation line of a patient's native mitral valve, expanding the spacer until regurgitation in the patient's mitral valve is adequately reduced (an inflatable device can allow a physician to make fine adjustments to the final size and configuration of the spacer based on information received during the delivery process), manipulating the anchors of the spacer to an open position, capturing the native leaflets between the anchors and the body of the spacer, and then manipulating the anchors to a closed position, thereby clipping the spacer to the native mitral valve leaflets.
The first anchor 804 can comprise first and second end portions 810, 812 which can be coupled to the first end portion 816 of the main body 802, and a loop portion 814 which can extend between the first and second end portions 810, 812. The first and second end portions 810, 812 can extend away from the first end portion 816 of the body 802, then curl back and extend toward the second end portion 818 of the main body 802. The loop portion 814 can be coupled to the first end portion 810, extend generally toward the second end portion 818 of the main body 802, curl back and extend toward the first end portion 816 of the main body 802, and be coupled to the second end portion 812.
Thus, the first anchor 804 can be coupled to the first end portion 816 of the main body 802 and extend along the side of the main body 802 toward its second end portion 818. The second anchor 806 can have a similar structure, and can be coupled to the main body 802 such that it extends along an opposing side of the main body 802. In this embodiment, the spacer 800 can be clipped to native tissues by pinching the native tissues between the anchors 804, 806 and the respective sides of the main body 802. The anchors 804, 806 can be made from various suitable materials, and in one exemplary embodiment can be fabricated from the shape-memory material Nitinol. The anchors 804, 806 in the illustrated embodiment are fabricated from separate pieces of material from the main body 802, and are coupled to the main body 802 using coupling mechanisms 820. The coupling mechanisms 820 can be, for example, crimping rings that extend around a strut at the first end 816 of the main body 802 and an adjacent portion of an anchor. In alternative embodiments, however, the anchors 804, 806 and the main body 802 can be fabricated integrally with one another (i.e., from a single piece of material). As best shown in
In some embodiments, the delivery device 850 can be similar to the delivery device 2000 described in U.S. Patent Application Publication No. 2011/0137397 or the delivery devices described in U.S. Provisional Patent Application No. 61/760,577, and can be used to implant prosthetic devices via methods similar to those described therein.
As shown in
Prosthetic spacers described herein can be delivered using minimally invasive approaches.
The device 920 can then be distally advanced so that the native mitral valve leaflets are positioned between the splayed apart anchors 804, 806, and the body 802. The inner sheath 924 can then be retracted so that the body 802 is no longer confined within the inner sheath 924 and can radially expand to an expanded configuration between the native mitral valve leaflets. In some embodiments, the body 802 can expand such that the native leaflets are pinched between the body 802 and the anchors 804, 806. In alternative embodiments, as described above, the mechanism for forcing the anchors 804, 806 to splay apart can be actuated to allow the anchors 804, 806 to move radially inward toward the main body 802, thereby pinching the native leaflets between the main body 802 and the anchors 804, 806.
The system 920 can then be proximally retracted so that the native mitral valve leaflets are positioned between the splayed apart anchors 804, 806, and the body 802. The inner sheath 924 can then be retracted so that the body 802 is no longer confined within the inner sheath 924 and can radially expand to an expanded configuration between the native mitral valve leaflets. In some embodiments, the body 802 can expand such that the native leaflets are pinched between the body 802 and the anchors 804, 806. In alternative embodiments, as described above, the mechanism for forcing the anchors 804, 806 to splay apart can be actuated to allow the anchors 804, 806 to move radially inward toward the main body 802, thereby pinching the native leaflets between the main body 802 and the anchors 804, 806.
In any of the four approaches described above, once the native leaflets have been captured by the spacer 800, the delivery system 920 can be retracted and removed from the patient's vasculature. The spacer 800 can remain in the native mitral valve region, with the main body 802 being situated between the two native leaflets, thereby helping to reduce or prevent mitral regurgitation. It will be understood that similar techniques can be used to deliver a spacer to the native aortic, tricuspid, or pulmonary valves, depending on the needs of the patient.
In any of the four approaches described above, a marker catheter or other similar device can be used to help coordinate delivery and ensure that a desirable delivery position is achieved. An exemplary suitable marker catheter can include a standard catheter designed for angiograms, for example, a catheter made of a relatively low-density plastic material having relatively high-density metal marker bands (e.g., radiopaque marker bands) disposed at regular intervals thereon. Thus, the device can be introduced into a patient's vasculature and can be viewed under echocardiography or fluoroscopy. Alternatively, a marker wire can be used in place of the marker catheter. Another suitable alternative technique is left atrium angiography, which can help a physician visualize components of a patient's heart.
A marker catheter or marker wire can be introduced into a patient's vasculature and advanced to specific areas of the vasculature near a patient's heart. For example, a marker catheter can be advanced from a patient's jugular or femoral vein into the right atrium, then into the patient's coronary sinus. As another example, a marker catheter can be advanced from a patient's femoral artery to the patient's circumflex artery. As another example, a marker catheter can be advanced into a patient's left atrium. Once situated in the coronary sinus, circumflex artery, left atrium, or other suitable area of a patient's vasculature, the marker catheter can be used to aid a physician in delivering and ensuring desirable implantation of a prosthetic device. For example, the coronary sinus extends around the heart near the location and elevation of the mitral valve and thus can help a physician to properly size and position a prosthetic device for implantation.
For example, the patient's vasculature can be viewed under echocardiography, fluoroscopy, or other visualization technique which allows a physician to view the prosthetic device being delivered and the marker catheter. A physician can first view the devices along an axis extending from the patient's left atrium to the patient's left ventricle (referred to as a “short axis”). By viewing the devices along the short axis, a physician can deploy (such as by inflating a balloon on which an implantable device is mounted) an implantable prosthetic device and expand portions of the device to desired sizes and/or configurations based on the size and location of the marker catheter, which can provide an estimate of the size of features of the native mitral valve. Alternatively or additionally, a physician can use the marker catheter to obtain an estimate of the size of a patient's native heart valve, from which estimate a prosthetic device to be implanted in the patient's native heart valve can be selected from a set of devices having differing sizes, e.g., a set of devices having differing diameters.
A physician can also view the devices along an axis perpendicular to the short axis (referred to as a “long axis”). The long axis can have several orientations, such as from commissure to commissure, but in one specific embodiment, the long axis is oriented from the A2 location to the P2 location of the native mitral valve. By viewing the devices along the long axis, a physician can align an implantable prosthetic device relative to the marker catheter at a desirable location along the short axis, such that an atrial anchor of the implantable device is situated in the left atrium (above the marker catheter) and a ventricular anchor of the implantable device is situated in the left ventricle (below the marker catheter).
The nosecone 958 can have a small pore, or opening, or slit, 966, which can extend through and along the length of the nosecone 958. In accordance with suitable delivery methods making use of a guidewire such as guidewire 930, the guidewire can extend through the opening 966, thus eliminating the need for an opening or pore in a fabric layer. The spacer 950 can facilitate crossing of a native heart valve due to its tapered tip, which can also provide improvements in hydrodynamics during diastolic blood flow. When a guidewire is removed from the opening 966, the opening can close under its own resiliency and/or blood pressure, thus leaving a sealed spacer implanted at a native heart valve. Alternatively, or in addition, the opening 966 can be sufficiently small to prevent significant amounts of blood from travelling through the nosecone 958.
The multi-anchor spacers described herein offer several advantages over previous techniques for treating regurgitation in heart valves. For example, the multi-anchor spacers described herein can be used to treat patients whose native leaflets fail to coapt at all, whereas many previous techniques required some amount of native coaptation to be efficacious. Additionally, the spacers described herein (e.g., spacer 640) can treat eccentric jet regurgitation more readily than other known techniques. While embodiments have been illustrated with two and three anchors, the techniques described herein are generally application to spacers having any number of anchors.
For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.
Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. As used herein, the terms “a”, “an” and “at least one” encompass one or more of the specified element. That is, if two of a particular element are present, one of these elements is also present and thus “an” element is present. The terms “a plurality of” and “plural” mean two or more of the specified element.
As used herein, the term “and/or” used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C” or “A, B and C.”
As used herein, the term “coupled” generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items absent specific contrary language.
In view of the many possible embodiments to which the principles disclosed herein may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.
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|Citing Patent||Filing date||Publication date||Applicant||Title|
|US9750605||27 Mar 2015||5 Sep 2017||Caisson Interventional, LLC||Systems and methods for heart valve therapy|
|US9750606||30 Mar 2015||5 Sep 2017||Caisson Interventional, LLC||Systems and methods for heart valve therapy|
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|Cooperative Classification||A61F2/246, A61F2/2436, A61F2/2457, A61F2/2442, A61F2/2412, A61F2230/0069, A61F2/2466, A61F2/2454, A61F2/2463, A61F2250/0003, A61F2/2445, A61F2/243, A61F2/2433|
|6 Dec 2013||AS||Assignment|
Owner name: EDWARDS LIFESCIENCES CORPORATION, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CHAU, MARK;DELGADO, SERGIO;OBA, TRAVIS;AND OTHERS;SIGNING DATES FROM 20131009 TO 20131025;REEL/FRAME:031733/0219